UMIN-CTR Clinical Trial

Basic information
Public title	A study for evaluating the effect of the test food on relating nasal and ocular symptoms in an environmental exposure unit (EEU)
Acronym	A study for evaluating the effect of the test food on relating nasal and ocular symptoms in an environmental exposure unit (EEU)
Scientific Title	A study for evaluating the effect of the test food on relating nasal and ocular symptoms in an environmental exposure unit (EEU)
Scientific Title:Acronym	A study for evaluating the effect of the test food on relating nasal and ocular symptoms in an environmental exposure unit (EEU)
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of the test food on nasal and ocular symptoms
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Record during pollen exposure (the number of sneezes and nose blowing, visual analog scale of nasal blockage, nasal itching, eye itching, watery eyes, throat symptoms, sleepiness and daily life)
Key secondary outcomes	Record after exposure pollen (the number of sneezes and nose blowing, visual analog scale of nasal blockage, nasal itching, eye itching, watery eyes , throat symptoms, sleepiness, and daily life) visual analog scale of awaking. eosinophil of nasal mucus. Doctor observation of the nasal mucus and the nose

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake I period (test food) - washout period - Intake II period (placebo)
Interventions/Control_2	Intake I period (placebo) - washout period - Intake II period (test food)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Males and females from 20 to 69 years of age (2) Subjects who complained of nasal and ocular symptoms and judged. (3) Subjects who are judged as suitable for the study by the investigator. (4) Subjects who obtained the consent about participation in the study. (5) Subjects who do not take antiallergic drug account for more than half of whole.
Key exclusion criteria	(1) Subjects who constantly use health food richly containing involvement ingredient (2) Subjects who routinely take medicine affecting the test result. (3) Subjects who have severe nasal and eye symptoms affecting judgement of symptoms (4) Subjects who have a medical treatment (specific desensitization therapy) which may influence the outcome of the study. (5) Subjects who are engaged in drive a car or operate a hazardous machine. (6) Subjects judged as unsuitable for the study by the investigator for laboratory evidence or cardiopulmonary function. (7) Subjects who have a disease requiring regular medication or a history of serious disease for which medication was required. (8) Subjects who are liable to cause an allergy related to the study. (9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination. (10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. (11) Subjects who have participated in other clinical studies at the time of this study start (12) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. (13) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Eri Middle name Last name Saito
Organization	Asama Chemical. Co., Ltd.
Division name	Laboratory
Zip code	103-0001
Address	20-6, Nihonbashikodenmacho, Chuo-ku, Tokyo
TEL	03-3661-6282
Email	saito@asama-chemical.co.jp

Public contact
Name of contact person	1st name Chiharu Middle name Last name Goto
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	c.goto@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	Asama Chemical. Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	FURUKAWA Research & Consulting
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Aisei Hospital Ueno Clinic Research Ethics Committee
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 08 Month 22 Day
Date of IRB	2019 Year 08 Month 22 Day
Anticipated trial start date	2019 Year 09 Month 07 Day
Last follow-up date	2019 Year 10 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 06 Day
Last modified on	2020 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043259